Abbott Dragonfly OpStar Imaging Catheter recall flagged as Class I by FDA

2022-10-02 07:25:20 By : Ms. winnie yu

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

That’s the most serious level of a medical device recall, carrying the risk of serious injury or death. Five incidents, one injury and zero deaths were reported when Abbott initiated the recall on April 11.

The recall affects 4,800 devices in the U.S. from certain lots. Abbott is asking health care providers to stop using the devices.

Get the full story at our sister site, Medical Tubing & Extrusion.

Filed Under: Blog, Cardiovascular, Catheters, Food & Drug Administration (FDA), Imaging, News Well, Recalls, Regulatory/Compliance, Vascular Tagged With: Abbott, FDA

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